[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: [11C]donepezil PET

• Registration Number: NCT02012595
• Lead Sponsor: Per Borghammer

Brief Summary

AIM: Investigate wether there are differences in the parasympathetic nervous system in Parkinsons patients compared to controls.

MATERIALS AND METHODS: We use the tracer \[11C\]donepezil to image the parasympathetic nervous system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged 40-80 in our study. The participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. The subjects also have an MRI scan of the brain. Then PET/CT scans with \[11C\]donepezil are conducted - once for the upper abdominal region and once for the head region. For evaluating the function of the parasympathetic nervous system gastric emptying time, heart rate variability and salivary flow will be measured. These measureless will be correlated to the PET findings.

PERSPECTIVES: The study will potentially result in the development of a PET ligand for imaging the parasympathetic nervous system. This will have applications for research in Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-31
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age 40-80 years

Exclusion Criteria

• dementia,
• psychiatric diseases,
• serious medical illness including any type of previous cancer
• any drug with known interaction with the autonomic nervous system
• metal in the body (because of MRI scan)
• pregnancy or breast feeding (because of radiation due to PET/CT)
• known diseases of the salivary glands, stomach, intestines.
• Prior major surgery to salivary glands, esophagus, stomach.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's patients	[11C]donepezil PET	Participants with Parkinson's Disease
Healthy Controls	[11C]donepezil PET	Healthy participants

Primary Outcome Measures

Name	Time	Method
Distribution volume of [11C]donepezil in internal organs	The distribution volume of [11C]donepezil is measured at "Day 1" by PET/CT scanning each participant. The data analysis is done when all participants have completed the study.	Our primary endpoint is the distribution volume of \[11C\]donepezil in internal organs (including salivary glands, heart, stomach and intestines) in Parkinson's patients compared to controls.

Trial Locations

Locations (1)

Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark